Kornimate/medical-research-clean huggingface dataset:
melatonin treatment for night-eating syndrome

Conditions: Night-eating Syndrome

Summary: this is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial to test the effectiveness of melatonin treatment versus placebo on symptoms of night eating syndrome (nes). the investigators will also look at the effect of melatonin treatment on weight, metabolic parameters and sleep parameters in individuals with nes.

night eating syndrome (nes) is a unique disorder characterized by a delayed pattern of food intake in which recurrent episodes of food consumption occurs after the evening meal and/or during nocturnal awakenings. diagnostic criteria for nes include: (1) recurrent episodes of night eating, as manifested by eating after awakening from sleep or by excessive food consumption following the evening meal, (2) awareness of those eating episodes, and (3) significant distress or impairment caused by the disorder. exclusion criteria are binge-eating disorder or another mental disorder, as well as medical disorders or medications that might better explain the disordered eating pattern. nes is also more common among patients with insomnia, eating disorders, and other psychiatric disorders. 100 participants with night eating syndrome will be recruited from the general population. they will be randomized to either a commercially available rapid-release formulation of melatonin (5 mg) or matching placebo capsules, that will be administered once a day for a total of 8 weeks. participants will attend a screening appointment, a baseline assessment and additional research assessment visits every other week for the 8 weeks.

Eligibility criteria:
inclusion criteria: 1. 18 - 65 years of age 2. english speaking 3. meet dsm-v (diagnostic and statistical manual - version 5) criteria for night eating syndrome (nes) exclusion criteria: 1. unable to provide informed consent 2. presence of alcohol/substance dependence 3. presence of other eating disorders such as binge eating disorder, anorexia nervosa. 4. significant uncontrolled systemic illness (e.g. chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, chronic infectious disease, chronic autoimmune disease) 5. women who are pregnant or breastfeeding 6. allergy or hypersensitivity to melatonin
effects of mulligan and cyriax approach in patients with subacute lateral epicondylitis.

Conditions: Lateral Epicondylitis

Summary: lateral epicondylitis (le) is a pain causing musculoskeletal disease which mainly occurs due to the over exertion or over use of extensors of wrist mainly ecrb and pain is felt at the origin of common extensor tendon. this study was focused to assess the effectiveness of cyriax approach and mulligan approach to improve the functional status of sub acute lateral epicondylitis patients through patient related tennis elbow evaluation form.

a total of 39 athletes with knee pain were recruited and randomly divided into two groups. 30 subjects fulfilled the inclusion criteria and were part of this trial, 15 in each group.the data was collected through general demographic questionnaire, prtee questionnaire to determine the level of pain and functional disability and hand grip strength chart to measure grip strength while having epicondylitis.

Eligibility criteria:
inclusion criteria: * age group 20-50 years of both gender. * vas \< 7 * positive mills test and cozens test. * local tenderness on palpation over lateral epicondyle of the humerus. * from sub-acute to chronic more than 2 weeks. exclusion criteria: * any previous pathology of bone around elbow. * corticosteroid injection in the preceeding 3 months. * absence of clinical signs of tennis elbow. * any other systemic illness like metabolic, metastatic, infective disorders. * any other neurological abnormalities. * allergies to mulligan tape.

Keywords: patient rated tennis elbow evaluation (prtee) mobilization with movement deep transverse friction massage
comparison of two basal insulins for patients with type 2 diabetes taking oral diabetes medicines and exenatide

Conditions: Diabetes Mellitus, Type 2

Summary: this study will compare insulin lispro protamine suspension (ilps) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * must have type 2 diabetes * must be at least 18 years of age and less than 75 years of age * must be taking exenatide 10 micrograms twice a day (bid) for at least 3 months * must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (tzd). doses must be at or above the following: metformin--1500 mg/day, sulfonylurea--1/2 the maximum daily dose according to the product label, tzd--30 mg/day pioglitazone * must have a hemoglobin a1c greater than or equal to 7.0% and less than or equal to 10.0% exclusion criteria: * must not have used insulin on a regular basis during the past 2 years * must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months * must not have had more than one episode of severe hypoglycemia in the past 6 months * must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease * must not be pregnant or intend to get pregnant during the course of the study
pet/mr in post stroke cardiac inflammation study

Conditions: Stroke; Inflammation

Summary: patients with stroke have a 25x higher risk of cardiovascular complications within the first 30 days of the event compared to individuals without stroke. the mechanisms behind these complications are not well understood. evidence suggests that inflammation plays a central role. with the present proof-of-concept prospective cohort study, the investigators aim to demonstrate that patients develop cardiac inflammation after stroke by performing positron emission tomography (pet) magnetic resonance imaging (mri) of the heart within 15 days after stroke. as a secondary aim, the investigators will evaluate whether post-stroke cardiac inflammation persists at 3 months after stroke. the control group will be comprised of age- and sex-matched individuals without stroke.


Eligibility criteria:
inclusion criteria: * age ≥18 years willing to cons age ≥18 years willing to consent * patients with acute ischemic stroke in the right or left mca territory, admitted to university hospital, london health sciences centre (lhsc) or evaluated at lhsc's urgent tia and stroke prevention clinic. acute ischemic stroke is defined as acute onset focal symptoms matching an acute brain infarct documented on a head ct or on diffusion weighted imaging (dwi) mri of the brain showing restricted diffusion. * willing to consent. exclusion criteria: * history of known heart disease defined as known atrial fibrillation, prior myocardial infarction, coronary artery disease, heart failure, prior cardiovascular surgery or percutaneous intervention * stroke in the previous 3 months before the qualifying stroke. * high-sensitivity troponin-t (hs-tnt) \>100 ng/l on routine standard of care acute stroke bloodwork. * clinically or neurologically unstable patients as per the treating physician. * ongoing infection or recent infection within the previous 3 months. * surgery within 3 months before the stroke. * concurrent inflammatory conditions (connective tissue diseases, rheumatological disease, etc.) or use of anti-inflammatory medications. * contraindications to the use of gadolinium (e.g., pregnancy, stage iv renal insufficiency) * subjects will be excluded if they fail the st. joseph's health care standard mri screening questionnaire. briefly, this questionnaire screens for: heart pacemakers / wires, aneurysm clips, shunt / surgical clips, shrapnel / bullets, dentures or metal braces, intra-uterine device, heart valves, ear implants, prostheses, medication patches (nicoderm, habitrol, transderm-nitro, etc.), claustrophobia, history of a head or eye injury involving metal fragments. patients with an egfr \< 40 will be excluded, as impaired renal function places the patient at a higher risk for a rare reaction to gd-dtpa, the mri contrast agent.

Keywords: stroke pet/mri inflammation heart
test of qls device to detect early cataracts

Conditions: Cataract; Healthy

Summary: this study will test the reliability of an instrument called the quasi elastic laser scattering device (qls) in detecting early changes in cataract formation. surgery is currently the only treatment for cataracts. many laboratories, however, are researching drugs to reverse, delay or prevent cataract formation. anti-cataract drugs presumably would be most effective given early in the course of disease. when clinical trials of these drugs are begun, dependable and standardized methods for documenting and monitoring lens opacities will be needed to test their effectiveness. the qls was designed to detect the earliest molecular changes in cataract development. this study will evaluate the usefulness and reliability of this instrument in measuring these changes. normal volunteers and patients with cataracts in this study will have a standard eye examination, including a vision test and eye pressure measurement. the pupils will be dilated for qls testing and for examination of the retina. photographs of the retina may be taken. the qls test uses a very dim laser light similar to that used to scan grocery items in the supermarket. the laser beam is projected into the lens of the eye, and the scattered light is collected and analyzed to determine normal and abnormal molecular interactions in the lens. two measurements will be done for each eye. the test will be repeated in 6 months to determine reproducibility of the system.

recently, a device has been created to determine molecular interactions that occur in the nucleus of the lens, called quasi elastic laser scattering device (qls). preliminary studies have shown its potential in the detection of the earliest changes occurring in cataract, at the stage where anticataract treatment would theoretically be most effective in reversing, delaying or preventing cataracts. a new miniaturized version of this device has been developed by nasa using low energy lasers and offered for further development and testing at the nei. we therefore propose to conduct a preliminary study to evaluate the usefulness and reproducibility of this instrument for quantitating lens changes.

Eligibility criteria:
patients 18 years or older will be admitted to this study. there will be no gender or sex bias in the recruitment. three subjects who are normal volunteers below age 40 and three subjects who are normal volunteers above age 40 will be recruited. these normal volunteers should have clear lenses with locs ii clinical score for nuclear opalescence of 0.5 or less. in addition, 3 subjects who have early nuclear cataract (locs ii/nuclear opalescence -2) will also be recruited for the study. qls data will be obtained on each eye of the normal and cataractous subjects in the nuclear region. no patients who have uveitis, glaucoma and who are thought to be at risk for an adverse reaction to pupil dilation, or have a history of allergic reaction to one of the dilating agents that will be used.

Keywords: aging cataract eye human lens normal volunteer
improvement of nutritional status in elderly residents of long-term facilities

Conditions: Nutrition Disorders

Summary: elderly persons in long-term facilities often have denutrition, associated with a bad oral and dental status. yet, many elderly persons don't attend dentist care and when they have dental prothesis, do not often use them during meals. the impact of a rehabilitation of dental function on their nutritional status has not been proven. the objective of this study is to assess the impact of 2 strategies aimed to restore a good nutritional status, among patients with slight denutrition.

two interventions are evaluated during a 1 year study period, with a 4 arms factorial design. the "dentary" intervention implies a trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash. the "nutrition" intervention consists in 1) comparing the meals and oral supplements administered with the dietary prescriptions and 2) incite patients to eat.

Eligibility criteria:
inclusion criteria: * geriatric nutritional risk index = 83.5 to 97.5; minimum age of 70 years old; living in long-term facilities; more than 6 months of anticipated length of stay exclusion criteria: * refusal to participate in the study

Keywords: elderly long-term facilities nutritional status
chinese herbal medicine treatment as adjunct therapy for parkinson's disease

Conditions: Parkinson Disease

Summary: background: parkinson's disease (pd) is a prevalent and debilitating condition. conventional medications cannot control all symptoms and may inflict adverse effects. a survey reported that chinese herbal medicine (chm) is frequently sought. existing chm trials were contradictory and often of poor quality due to a lack of methodological rigor. a national clinical guideline was drafted in china with diagnostic criteria and treatment strategy of chinese medicine (cm) patterns subgroups of pd. the suggested chm was found to exhibit a neuroprotective effect in in vitro and in vivo studies. this trial aims to preliminarily assess the effect of chm prescribed based on pattern differentiation on pd symptoms and patients' quality of life, and evaluate the feasibility of the trial design for a future large-scale trial. methods: this trial will be a pilot assessor- and data analyst blind, add-on, randomised, controlled, pragmatic clinical trial. 160 pd patients will be recruited and randomised into treatment or control groups in a 1:1 ratio. the trial will be conducted over 32 weeks. pd patients in the treatment group will be stratified into subgroups based on cm pattern and receive chm accordingly in addition to conventional medication (conm). the control group will receive conm only. the primary outcome will be part ii of the movement disorder society sponsored revision of unified parkinson's disease rating scale (mds-updrs). secondary outcomes will include part and total scores of mds-updrs, domain and total scores of non-motor symptom scale (nmss). adverse events will be monitored by monthly follow-ups and questionnaires. mixed models will be used to analyse data by jamovi and r. expected outcomes: the success of our trial will show that the pragmatic design with subgroup differentiation is feasible and can produce reliable results. it will also provide preliminary data of the effect of chm on improving clinical outcomes and quality of pd patients. data collected will be used to optimize the study design of the future large-scale clinical study. ethical clearance: ethical clearance of this study was given by the research ethics committee of hong kong baptist university (rec/20-21/0206).


Eligibility criteria:
inclusion criteria: 1. diagnosed with pd according to united kingdom parkinson's disease society brain bank (ukpdbb) diagnostic criteria 2. aged 18 to 80 years old 3. under stable conm treatment with no alteration of dosage in the past 30 days exclusion criteria: 1. secondary pd or atypical parkinsonian disorder 2. used antidepressants in the previous month 3. with concurrent psychiatric, mood, or other neurological disorders 4. suicidal (with suicidal thoughts in the past year) 5. with concurrent severe disorders, such as cancer and myocardial infarction 6. participation in another chinese herbal medicine clinical study 7. pregnant or breast-feeding 8. hoehn and yahr (h\&y) stage 4 or above 9. liver and renal function derangement

Keywords: chinese medicine pragmatic trial mds-updrs
phase iii study ：shr6390/placebo combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,human epidermal receptor 2 negative

Conditions: Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer

Summary: the study is to evaluate the efficacy and safety of shr6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,human epidermal receptor 2 negative. to observe the pk characteristics of shr6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,human epidermal receptor 2 negative.


Eligibility criteria:
inclusion criteria: 1. postmenopausal or premenopausal/perimenopausal female patients aged ≥18 years and ≤75 years old. 2. pathological examination diagnosed as invasive breast cancer with hr+ and her2-. 3. underwent radical resection of breast cancer. 4. the score of ecog was 0 - 1. 5. fertile women must have a negative serum pregnancy test within 7 days before randomization, and be willing to use acceptable non hormonal contraceptive measures. 6. with my consent and informed consent, i am willing and able to comply with the planned visit, study treatment plan, laboratory examination and other test procedures. exclusion criteria: 1. this pathological examination diagnosed as her2-positive breast cancer. 2. the history of any malignant tumor other than breast cancer within 5 years before randomization. 3. at the same time participate in other anti-tumor therapy clinical trials (including endocrine therapy or immunotherapy, etc.). 4. in the 6 months before randomization, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, , etc 5. inability to swallow, intestinal obstruction, or other factors that affect the administration and absorption of the drug. 6. there are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator believes are not suitable for participating in this study.
prognostic value of the urinary nerve growth factor in the patients with benign prostatic hyperplasia

Conditions: Benign Prostatic Hypertrophy With Outflow Obstruction; Overactive Detrusor

Summary: persistent detrusor overactivity (do) after transurethral prostatectomy results in symptomatic failure in more than one third of the patients. storage symptoms are major complaints in the early postoperative period after holmium laser enucleation of the prostate (holep). levels of the urinary nerve growth factor (ngf), produced by bladder urothelium and smooth muscle, are increased in the patients with overactive bladder (oab), and decreased after the oab symptoms were improved. also, urinary ngf levels are increased in patients with benign prostatic obstruction (bpo), but the changes of the ngf levels after relief of the bpo by the medical or surgical treatment have not been fully investigated. if the elevated urinary ngf levels are reduced after successful surgical treatment of bpo, measurement of urinary ngf could be a useful objective tool to assess the therapeutic outcomes of the operation. the aims of this study are to measure the urinary ngf levels in patients with bpo and to compare the results between the patients with detrusor overactivity (do) and without detrusor overactivity (non-do), average 2 weeks before holmium laser enucleation of the prostate (holep) procedure. after holep, urinary ngf levels are rechecked at the periods of postoperative 3 months and 6 months, and compare changes between the two groups.

* investigators are going to enroll age-matched control group and measure the urinary ngf levels as a baseline value (30 males). * investigators are going to enroll bpo patients group (do group 50 and non-do group 50 patients). * administration of the anti-cholinergic agents was reported to decrease urinary ngf levels. investigators are going to try to avoid the effect of anti-muscarinic drugs.

Eligibility criteria:
inclusion criteria: * male aged 50 yrs or greater * international prostatic symptom score \>= 12 * bladder outlet obstruction confirmed by pressure-flow study (booi \> 20) * ability and willingness to correctly complete the micturition diary and questionnaire * capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits exclusion criteria: * patients with urologic malignancies such as prostate cancer and bladder cancer * patients underwent urethral, prostate surgery * patients with urethral stricture or bladder diverticulum or bladder neck contracture * any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Keywords: benign prostatic obstruction (bpo) detrusor overactivity (do) urinary nerve growth factor (ngf)
sevoflurane general anesthetic and spatial memory in humans

Conditions: Spatial Memory Disorder

Summary: the goal of this observational study is to learn about the effect of general anesthetic on spatial memory in adults who will undergo to an elective surgery. the main question it aims to answer is: • a surgical event under general anesthesia with sevoflurane transiently impairs spatial memory in humans and induces an increase in inflammatory cytokines. participants will perform a virtual maze test and plasma samples will be taken before and after surgery.

postoperative cognitive dysfunction (pocd) occurs after a surgical event under general anesthesia and is characterized by a decline in one or more cognitive functions. pocd is defined as delayed neurocognitive recovery if it takes place within the first 30 days, if it exceeds that time it is known as postoperative neurocognitive disorder. the pathogenesis of this dysfunction is not entirely clear. however, the most accepted hypothesis would be neuroinflammatory, which would take place due to the contribution of inflammatory factors typical of surgical trauma under general anesthesia, with anesthetics such as sevoflurane. consequently, one of the areas most susceptible to this inflammatory environment would be the hippocampus, a structure responsible for learning and memory. spatial memory is responsible for encoding and retrieving information about the environment and spatial orientation. to confirm this hypothesis, an elective laparoscopic cholecystectomy under general anesthesia with sevoflurane, plasma measurement of cytokines interleukin-1beta and tumor necrosis factor-alpha and virtual navigation tests will be performed before and after an elective laparoscopic cholecystectomy under general anesthesia with sevoflurane, in order to establish a correlation between the inflammatory component and performance in the virtual navigation test. the above will allow us to elucidate the possible occurrence of a delayed neurocognitive recovery related to spatial memory in middle-aged individuals, providing new background related to an age group that has been little studied, with a non-minor incidence (30%), where the evident concern arises for being a population exposed to activities or environments of greater risk, linked to work, sport, driving, among others. this finding will guide the doctor and the patient to decide or take the necessary safeguards when proceeding with a surgical intervention in the middle-aged population.

Eligibility criteria:
inclusion criteria: * candidate for elective laparoscopic surgery of cholecystectomy. * age 30 to 50 years. exclusion criteria: * visual or hearing difficulties. * malignant hyperthermia. * being treated with centrally acting drugs, such as anxiolytics, antidepressants, antipsychotics, anticonvulsants, anticholinergics, and first-generation antihistamines. * present a disorder of the sphere of neuropsychiatry * substance abuse disorder.